gelato topical anesthetic

Generic: benzocaine

Labeler: mycone dental supply co., inc dba keystone industries and deepak products inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name gelato topical anesthetic
Generic Name benzocaine
Labeler mycone dental supply co., inc dba keystone industries and deepak products inc
Dosage Form SPRAY, METERED
Routes
DENTAL
Active Ingredients

benzocaine 11.4 g/57g

Manufacturer
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc

Identifiers & Regulatory

Product NDC 68400-323
Product ID 68400-323_15d7eb39-c284-291a-e063-6294a90adc6a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2013-07-29

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68400323
Hyphenated Format 68400-323

Supplemental Identifiers

RxCUI
1435490 1435495
UNII
U3RSY48JW5
NUI
N0000185508 N0000175629 N0000184306 M0000728

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gelato topical anesthetic (source: ndc)
Generic Name benzocaine (source: ndc)
Application Number M022 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 11.4 g/57g
source: ndc
Packaging
  • 57 g in 1 BOTTLE, SPRAY (68400-323-35)
source: ndc

Packages (1)

68400-323-35 57 g in 1 BOTTLE, SPRAY (68400-323-35)

Ingredients (1)

benzocaine (11.4 g/57g)

Linked Drug Pages (1)

Gelato Topical Anesthetic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "15d7eb39-c284-291a-e063-6294a90adc6a", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5"], "rxcui": ["1435490", "1435495"], "spl_set_id": ["9991de96-99a1-42f0-9ddd-e530ca9ceab1"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "57 g in 1 BOTTLE, SPRAY (68400-323-35)", "package_ndc": "68400-323-35", "marketing_start_date": "20180901"}], "brand_name": "Gelato Topical Anesthetic", "product_id": "68400-323_15d7eb39-c284-291a-e063-6294a90adc6a", "dosage_form": "SPRAY, METERED", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "68400-323", "generic_name": "Benzocaine", "labeler_name": "Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gelato Topical Anesthetic", "active_ingredients": [{"name": "BENZOCAINE", "strength": "11.4 g/57g"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20130729", "listing_expiration_date": "20261231"}